Early clinical experience with a new tubular equine pericardial stentless aortic valve.

BACKGROUND: This study details a single-center experience with the 3F Therapeutics stentless aortic bioprosthesis(investigational device) and is part of a prospective,nonrandomized worldwide multicenter study. We assessed the implantation procedure and the valve's efficacy in terms of early mortality and morbidity and early echocardiographic valve performance.

METHODS: Between June 2001 and March 2004, 24 patients (14 men/10 women) underwent aortic valve replacement(AVR) with a 3F valve. Mean age was 72 +/- 13 years(range, 31-88 years). Combined revascularization was performed in 12 patients; 1 patient received biatrial ablation therapy, 1 patient a myectomy, and 3 patients combined carotid endarterectomy. Echocardiographic systolic gradient and valve performance were investigated intra- and postoperatively by Doppler echocardiography.

RESULTS: There were 2 perioperative deaths, 1 non-valve related, due to aortic rupture in an 83-year-old woman, and 1 fatal cerebral embolism in a 77-year-old woman 5 days postoperatively. Cardiopulmonary bypass time was 102 +/- 32 minutes,aortic cross-clamp time was 79 +/- 24 minutes. Sizes for implanted 3F valves were 5 x 23 mm, 6 x 25 mm, 7 x 27 mm,and 6 x 29 mm. Follow-up systolic gradient results were 11.5 +/- 4.7 mm Hg at 30 days (n = 21), 11.4 +/- 4.5 mm Hg at 6 months (n = 18), and 13.3 +/- 4.4 mm Hg at 12 months (n =13). During the follow-up period trivial central aortic valve regurgitation was found in 6 patients.

CONCLUSION: The 3F aortic valve shows favorable preliminary hemodynamic results. Owing to the new valve design,implantation technique is simplified compared with other stentless valves. Anticoagulation treatment is mandatory for the first 3 months postoperatively. Long-term observation is necessary to assess life span and durability.